While all moderate or high-risk sterile products must be compounded within the hospital cleanroom or by approved outsourced facilities, a significant proportion of low-risk compounding can occur on the patient unit and is performed by non-pharmacy healthcare personnel. These individuals require proper training and regular oversight to ensure that they conform to USP Chapter 797 in states that require that or meet the specific standards established by the state in which they practice, which are generally very similar.
Those in charge of unit inspections or compliance monitoring, such as pharmacists or infection preventionists, should ensure that personnel who are compounding preparations practice good hand hygiene, wear gowns, gloves and mask when compounding, understand how to perform glove fingertip sampling, and receive training on proper compounding technique with annual assessments.
In addition, all personnel working with compounded sterile products must clearly understand and be able to distinguish which medications must be used within the hour, which can only be used by one patient, and which can be used by multiple patients.
Unit inspectors should also monitor the physical environment in which compounding occurs outside the pharmacy. Personnel should prepare all compounded sterile products (CSPs) in a segregated compounding area that has no unsealed windows, adjacent sinks or doors to the outside or busy hallways. Medication room and medication storage area counters, equipment and floors should be cleaned and disinfected daily by trained staff and the ceilings, walls, shelving and bins should be cleaned according to environmental services policy. The medications should be stored under ideal conditions; if any adverse condition occurs, such as a broken refrigeration unit, the issue should be identified and corrected within four hours or the medications should be discarded. Only authorized personnel should enter the medication room or storage area and they should never bring food or drink into the rooms.
Some hospitals have added locked cabinets within patient rooms. When a patient is discharged, all opened medications should be discarded. If the patient is on isolation precautions, all medications stored in the room must be discarded upon discharge, whether open or not. Refrigerators used for storing patient medication should be checked as patients are discharged to ensure that only medication for patients on the unit remains.
Using an electronic checklist management system like Simplifi+ MedStorage can help streamline inspections and keep all information accessible in one place online.
